Regulatory Affairs Program Manager

Regulatory Affairs Manager – UC Irvine

UC Irvine, founded in 1965, is a leading public research university located in Orange County, California. The Alpha Stem Cell Clinic (ASCC) is a central infrastructure that supports stem cell clinical research and clinical trial infrastructure at UC Irvine.

• Serve as a senior‑level expert in clinical research protocols and regulatory processes within the Alpha Clinic.
• Lead and innovate in regulatory affairs, designing large‑scope, high‑complexity research projects.
• Apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity.
• Mentor cross‑functional teams and interface with other extended study teams.

• Advanced knowledge of Federal and regulatory policies, ICH and GCP, and clinical research practices.
• Advanced regulatory requirements knowledge and ability to lead multiple projects in a fast‑paced environment.
• Critical thinking, problem solving, creativity, and clear communication skills.
• Advanced interpersonal and teamwork skills, including leadership and collaboration.
• Ability to use clinical trial management systems and clinical information/documentation application programs.
• Bachelor’s degree in a related field and 3–5 years of regulatory experience.

We offer a wealth of benefits, including medical insurance, retirement savings plans, vacation time, and additional perks. Please see our compensation practices and benefits for more information.

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC Anti‑Discrimination Policy. We are committed to attracting and retaining a diverse workforce. UCI provides reasonable accommodations for applicants with disabilities upon request.